Tissue repair assembly

ABSTRACT

A tissue repair assembly for attachment of tissue to bone or tissue to tissue having a soft anchoring implant 100 with a length of suture 120 there through for tensioning the implant and facilitating attachment of other tissue. The implant 100 is a soft, flexible, three-dimensional structure that has a resident volume 200. An inserter tube 310 facilitates the placement of the implant 100 into bone or adjacent soft tissue where it may be deployed. Upon deployment, the soft anchoring implant 100 shortens axially and expands radially, achieving a larger diameter than the hole through which it was placed, thus resisting pull out.

CROSS-REFERENCES TO RELATED APPLICATIONS

The present application claims the benefit of U.S. ProvisionalApplication No. 61/559,672 (Attorney Docket No. 92958-806535 (000500US),filed on Nov. 14, 2011, the full disclosure of which is incorporatedherein by reference.

BACKGROUND

There is an ever-increasing demand for more minimally invasive surgicaltechniques. The lower morbidity seen in endoscopic and arthroscopicsurgery makes them very appealing to both patients and physicians. Thesetechnologically-advanced procedures include many forms of soft tissue tosoft tissue repairs and soft tissue to bone repair. Examples of theseprocedures in orthopedic surgery include rotator cuff repair, labralrepair, biceps tenodesis, and anterior cruciate ligament reconstruction.Other examples in other surgical subspecialties include, but are notlimited to, hernia repair, hysterectomies, and laparoscopic gastricbypass.

Many orthopedic surgery procedures involve the use of anchoring devicesthat attach soft tissue to bone. Most of these procedures and techniquesrely on the use of polymers, metal, or biodegradable compounds. The useof these materials often requires relatively large holes placed in bone.If these devices ever loosen, one is faced with the issue of having apotentially hard device in a joint, which can place the patient at riskfor developing arthritis. Certain polymeric devices, such as those madewith polylactic acid (PLA), can weaken bone, predisposing the patient tofracture. Finally, metal devices can cause scatter on MRI, makingfollow-up MRI's inaccurate.

In addition, two major challenges facing all surgeons, and endoscopicsurgeons in particular, are knot tying and suture management. Use ofmultiple sutures can lengthen procedure time, producing higher risk tothe patient and lower repair predictability. Endoscopic knot tying isalso very challenging. For example, arthroscopic soft tissue bicepstenodesis requires multiple passes of suture through the tendon androtator cuff, followed by retrieval and knot tying which require a greatdeal of skill.

Solutions have been developed as an alternative to complex suturemanagement, particularly for soft tissue to bone fixation. For example,a device that uses only soft, flexible materials in repairs has a numberof key advantages: 1) The use of a less-invasive techniques forimplantation because the use of a material that is less brittle allowsthe use of smaller holes in bone; 2) The ease of MRI use in follow-up;3) No risk of a hard device lodging in a joint or body cavity; 4)Potentially better tissue incorporation, 5) Ultimately stronger bone andlower risk of fracture.

BRIEF SUMMARY

The following presents a simplified summary of some embodiments of theinvention in order to provide a basic understanding of the invention.This summary is not an extensive overview of the invention. It is notintended to identify key/critical elements of the invention or todelineate the scope of the invention. Its sole purpose is to presentsome embodiments of the invention in a simplified form as a prelude tothe more detailed description that is presented later.

In embodiments, a tissue repair system is provided including a deliverymechanism and an anchoring implant which may be preloaded into thedelivery mechanism. The anchoring implant may be configured to anchorwithin hard tissue such as bone or can act as a retaining anchor againstsofter tissue such as tendon or cartilage. One or more lengths ofstandard suture may be pre-attached to the anchoring implant.

In embodiments, the anchoring implants are generally soft and flexiblein nature. For example, the anchoring implants can be constructed ofsuture combined with braided material created from suture material. Thisbraided material may, in some embodiments, be constructed in a mannersuch that it creates a three-dimensional structure, such as that of asock or an elongated five-sided box. Upon being deployed, the softthree-dimensional structure may expand, or be compelled to expand from acompressed state. Upon radial or horizontal expansion, the structurecollapses to a shape that does not fit back through the hole throughwhich it was introduced, thus anchoring or retention is achieved.

In further embodiments, one or more lengths of suture may be threadedinto the above-referenced three-dimensional anchoring structure. Thesuture may be stitched into the braided material with a single ormultiple stitches. If multiple stitches are used, those stitches canextend around an outer edge of the sock, starting at the opening, goingto the toe, and returning up the other side to the opening, thusultimately ending the stitching at the same end as its beginning. Thesuture may be tied or loose. If loose, the suture is slideable throughthe braided material of the structure. When the suture ends aretensioned with some counter traction against the braided materialstructure, the braided material structure compresses axially and expandsradially.

In embodiments, the braided material of the anchoring implant isconstructed from multiple woven or crocheted threads or fibers. Thesefibers may be woven in such a manner (e.g., braided) as to be in asubstantially parallel orientation (with respect to the structure'saxis) when the structure is in a relaxed or tensioned state. When thestructure is in a compressed state, as when the sutures are tensionedwith counter traction, the structure expands radially as the fibers arere-oriented into a substantially orthogonal orientation (in relation tothe structure's axis).

In embodiments, the anchoring implant includes a braided pattern. Morespecifically, the structure utilized is a cylindrical, helically woundbraid, such as the common biaxial braid. Pulling the entire braid alongits length (i.e., putting the braid in tension) lengthens and narrowsit. The length is gained by reducing the angle between the braidedthreads of the wound braid at the crossing points of the threads causingthe braided threads to align mostly parallel, which also reduces theradial distance between opposing sides and hence the overallcircumference. When counter traction occurs, the opposite action occurs,and the braid contracts axially and expands radially, in this case byincreasing the angle between the braided threads.

In yet further embodiments of the anchoring implant, various methods ofconstruction are shown to achieve a soft three-dimensional structure.These include but are not limited to use of a single flat section ofbraided material that is folded in half with the edges bound by variousmethods. Also presented is a tubular shaped braided material constructwhich may one end bound to create the sock configuration.

Other embodiments of the soft anchoring structure are disclosed,including one in which a strand of suture is coiled upon itself to formthree-dimensional soft structure. Said coiled anchoring structure may beheld together with the use of a binding substrate or with the use ofstitches.

Another aspect of the invention involves various methods of using of adelivery tube to place and deploy the soft anchoring implant. In oneapproach, the implant may be loaded into the distal end of a deliverytube and deployed by using a pusher rod or tube to expel the implant.The implant would be deployed from the delivery tube in an axiallyaligned orientation from the proximal edge of a preformed hole in thetissue. An alternate embodiment involves placement of the preloadeddelivery tube at the bottom of the preformed hole, then withdrawing orunsheathing the delivery tube and leaving the implant in the preformedhole.

Also disclosed herein are methods and apparatus for tensioning the softsuture anchor in place while counter traction is applied via a backstopmechanism. These methods and apparatus describe the tensioning of thesutures and implant to a predetermined distance and/or force such thatmore consistent and reliable retention is achieved.

Embodiments herein are directed to a method of anchoring tissue to bone,including boring a hole into bone of a human or an animal, inserting aninserter tube into the hole, the inserter tube having a soft anchoringimplant mounted therein, a deployment rod mounted axially within theinserter tube and proximal of the soft anchoring implant, and a sutureextending through the inserter tube and connected to a distal end of thesoft anchoring implant with at least one end of the suture extending outof the hole; retracting the inserter tube while maintaining the softanchoring implant in the hole and the deployment rod against theproximal end of the soft anchoring implant, the inserter tube beingretracted at least to a proximal end of the soft anchoring implant;while maintaining the soft anchoring implant and a distal end of thedeployment rod in the hole, pulling said at least one end of the sutureto pull the distal end of the soft anchoring plant proximally, andshorten axially and expand radially the soft anchoring implant againstthe distal end of the deployment rod; and retracting the deployment rodfrom the hole while leaving the soft anchoring implant in the hole.

In embodiments, the soft anchoring implant includes a biaxial braid. Thebiaxial braid can include braided threads and when the soft anchoringimplant is installed in the inserter tube, the angle between the braidedthreads of the wound braid is reduced at the crossing points of thebraided threads causing the braided threads to align mostly parallel,which also reduces the radial distance between opposing sides and hencethe overall circumference of the soft anchoring implant. Shortening theimplant axially and expanding it radially can include increasing theangle between the braided threads.

In embodiments, the at least one free end of the suture can extendthrough the inserter tube. Pulling can include, as examples, at leastone of tensioning the suture to a predetermined force or pulling thesuture a predetermined distance to expand the anchor in the bone.

Embodiments are also directed to a method of anchoring tissue to bone,including boring a hole into bone of a human or an animal, the holedefining a longitudinal axis; inserting a soft anchoring implant intothe hole with a deployment rod at the proximal end of the soft anchoringimplant, the soft anchoring implant defining a tube aligned axiallyalong the longitudinal axis, the tube defining distal and proximal endsand side walls, and the soft anchoring implant having a suture connectedto a distal portion of the soft anchoring plant, with first and secondends of the suture extending from the proximal end of the soft anchoringimplant; while maintaining the soft anchoring implant and a distal endof the deployment rod in the hole, pulling on the first and second endsof the suture to shorten axially and expand radially the soft anchoringimplant against the distal end of the deployment rod; and retracting thedeployment rod from the hole while leaving the soft anchoring implant inthe hole. In embodiments, the tube is compressible and/or expandable.

The soft anchoring implant can be, for example, a biaxial braid. If so,in embodiments, the biaxial braid includes braided threads and, when thesoft anchoring implant is installed in the inserter tube, the anglebetween the braided threads of the wound braid is reduced at thecrossing points of the braided threads causing the braided threads toalign mostly parallel, which also reduces the radial distance betweenopposing sides and hence the overall circumference of the soft anchoringimplant. Shortening axially and expanding radially the biaxial braidincludes increasing the angle between the braided threads.

In embodiments, pulling includes at least one of tensioning the sutureto a predetermined force or pulling the suture a predetermined distanceto expand the anchor in the bone.

In additional embodiments, an anchor for securing tissue to a bone ortissue to tissue is provided, the anchor including a soft anchoringimplant comprising a biaxial braid and for inserting into a hole in boneor tissue of an animal or human, the soft anchoring implant comprising atube aligned so as to define a longitudinal axis, the tube definingdistal and proximal ends and side walls; and a suture connected to thesoft anchoring implant, and extending parallel to the longitudinal axisalong one side of the sidewalls, across the distal end, and returningparallel to the longitudinal axis along an opposite side of thesidewalls, with first and second ends of the suture exiting adjacent theproximal end of the implant; wherein tensioning the first and secondends of the suture when the soft anchoring implant is installed in ahole in bone or through the tissue of an animal or a human causes theimplant to change from a first configuration where the tube of softanchoring implant is elongate into a second configuration where the tubeis compressed axially and extended radially so as to form an anchor inthe hole. The biaxial braid can include braided threads and, when thesoft anchoring implant is installed in the inserter tube, the anglebetween the braided threads of the wound braid is reduced at thecrossing points of the braided threads causing the braided threads toalign mostly parallel, which also reduces the radial distance betweenopposing sides and hence the overall circumference of the soft anchoringimplant. Shortening axially and expanding radially can be done, forexample, by increasing the angle between the braided threads.

In still further embodiments, a method of anchoring tissue to bone isprovided, including boring a hole into bone of a human or an animal, thehole defining a longitudinal axis; inserting a soft anchoring implantinto the hole with a deployment rod at the proximal end of the softanchoring implant, the soft anchoring implant comprising a structurealigned axially along the longitudinal axis, the structure definingdistal and proximal ends and side walls, and the soft anchoring implantbeing inserted in the hole in a retracted configuration where the sidewalls are retracted such that a diameter of the soft anchoring implantis smaller in diameter than a diameter of the soft anchoring implantwhen the soft anchoring implant is in a relaxed state; expanding thesoft anchoring implant to a diameter larger than its relaxed stateagainst the distal end of the deployment rod; and retracting thedeployment rod from the hole while leaving the soft anchoring implant inthe hole. Inserting can include inserting the soft anchoring implantfrom an inserter tube into which the soft anchoring implant is mounted,the inserter tube confining the soft anchoring implant into theretracted configuration. Inserting can also or alternatively includeinserting the inserter tube into the hole with the implant therein.

In still further embodiments, a method of deploying a soft suture anchorimplant is provided, including drilling a hole in the bone of an animalor human; inserting a soft anchoring implant into the hole, the softanchoring implant having a suture connected thereto; and tensioning thesuture to a predetermined force to expand the soft anchoring implant inthe bone. Tensioning can be accomplished, for example, by twisting aknob in the inserter handle or by activating a lever on the inserterhandle.

In yet still more embodiments, a method of deploying a soft sutureanchor implant is provided, including drilling a hole in the bone of ananimal or human; inserting a soft anchoring implant into the hole, thesoft anchoring implant having a suture connected thereto; and pullingthe suture a predetermined distance to expand the soft anchoring implantin the bone. Pulling the suture a predetermined distance can beaccomplished, for example, by twisting a knob in the inserter handle orby activating a lever on the inserter handle.

In additional embodiments, an anchoring implant for anchoring a sutureto bone or tissue is provided, including an implant constructed of abiaxial braided material and a suture connected to the implant. Thebiaxial braided material can be configured to define a resident volumewhen in a relaxed state, a substantially reduced resident volume whenloaded into an insertion device, and substantially no resident volumewhen fully deployed to tissue.

In embodiments, a device for installing a suture anchor into a human oranimal patient is provided, including a handle; an inserter tubeconnected to the handle, the inserter tube defining a longitudinal axisand an elongate pocket inside the insert tube, arranged along thelongitudinal axis, and for receiving an implant; a deployment rodslidably received in the inserter tube and proximal of the pocket; theinserter tube, the deployment rod, and the handle defining an internalpassageway for a suture that attaches to an implant in the pocket; andan actuator for translating the deployment rod relative to the insertertube which, when an implant is in the pocket, and the actuator isactuated, the deployment pushes the implant out of the pocket. A suturepuller mechanism can be included for tensioning a suture that extendsthrough the passageway and is attached to an implant, the suture pullerbeing configured to pull the suture after the deployment rod has pushedthe implant out of the pocket, so that the suture tensions the implantagainst a distal end of the deployment rod. The suture puller mechanismcan include a mechanism for limiting pulling of the suture to apredetermined distance and/or a mechanism for limiting pulling of thesuture to a predetermined force.

Additional embodiments are directed to a method of anchoring tissue totissue, including passing an inserter tube through one or more pieces oftissue such that an open end of the inserter tube extends beyond thetissue, the inserter tube containing one or more soft anchoringimplants, each of said soft anchoring implants defining a tube alignedaxially along the longitudinal axis, the tube defining distal andproximal ends and side walls, and the soft anchoring implant having asuture connected to a distal portion of the soft anchoring plant, withfirst and second ends of the suture extending from the proximal end ofthe soft anchoring implant; for each of said plurality of soft anchoringimplants: pushing the soft anchoring implant into the space on theopposite side of the tissue, retracting the insertion tube while leavingthe soft anchoring implant on the other side of the tissue, and pullingon the suture to shorten axially and expand radially the soft anchoringimplant against the tissue surface to provide retention.

For a more comprehensive understanding of the nature and advantages ofthe present invention, reference should be made to the ensuing detaileddescription and accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a soft anchoring implant shown with asingle suture threaded through it.

FIG. 2 is a perspective view of the soft anchoring implant shown withmultiple sutures threaded through it.

FIG. 3 is a perspective view of the soft anchoring implant shown withtwo sutures threaded through it in a crossing configuration.

FIG. 4 is a perspective view of the soft anchoring implant constructedfrom braided material that is rolled into a conical shape.

FIG. 5 is a perspective view of the soft anchoring implant constructedby layering two braided material structures.

FIG. 6 is a perspective view of another embodiment of a soft anchoringimplant shown as constructed from a single suture coiled upon itself ina stacking manner.

FIG. 7 is a perspective view of another embodiment of a soft anchoringimplant shown as constructed from braided material in a tubular shapewith a distal end bound shut.

FIG. 8 is a perspective view of another embodiment of a soft anchoringimplant shown as constructed from braided material in a tubular shapewith a proximal end bound shut, the suture strand originating from theshut end.

FIG. 9 is a perspective view of another embodiment of a soft anchoringimplant shown as constructed from a braided material in a tubular shapewith one both ends bound shut.

FIG. 10 is a perspective view of still another embodiment of a softanchoring implant shown as constructed from a flat section braidedmaterial folded in half with the sides bound shut with adhesive.

FIG. 11 is a perspective view of yet still another embodiment of a softanchoring implant shown as constructed from a flat section braidedmaterial folded in half with the sides bound shut by sewing.

FIG. 12 is a perspective view of another embodiment of a soft anchoringimplant shown as constructed from a flat section braided material foldedin half with the sides bound shut by heat sealing.

FIG. 13 is a perspective view of even another embodiment of a softanchoring implant shown as constructed from a flat section braidedmaterial folded in half with the sides bound shut by mattress stitching.

FIG. 14 is a side view of a soft anchoring implant formed of coarse,braided material, with the braided material in a relaxed,as-manufactured state prior to deployment showing the verticalorientation of the fibers.

FIG. 15 is a perspective view of the soft anchoring implant of FIG. 14in an elongated, compressed state prior being loaded into the inserter.

FIG. 16 is a partial section view of the soft anchoring implant of FIG.15 in an elongated, compressed state loaded in the inserter tube.

FIG. 17 is a side view of the soft anchoring implant of FIG. 14 in acompressed state after deployment showing the substantially horizontalorientation of the fibers.

FIG. 18 is a section view of an embodiment of a tissue repair deliverysystem.

FIG. 19 is a perspective view of the tissue repair delivery system ofFIG. 18.

FIG. 20 is a perspective view of internal components of the tissuerepair delivery system of FIG. 19.

FIG. 21A is a perspective view of the tissue repair delivery system withimplant loaded.

FIG. 21B is a perspective view of the tissue repair delivery system withimplant deployed.

FIG. 21C is a perspective view of the tissue repair delivery system withimplant deployed and tensioned/expanded.

FIG. 22 is an exploded perspective view of a tissue repair deliverysystem with a paddle-type suture tensioning mechanism.

FIG. 23 is a perspective view of a tissue repair delivery system with alever-type suture tensioning mechanism.

FIG. 24 is a perspective view of a tissue repair delivery system with aspool-type suture tensioning mechanism.

FIG. 25 is a perspective view of an embodiment of a suture retentiondisc with a suture post in accordance with embodiments.

FIG. 26 is a partial section view of a tissue repair delivery systemwith an internal threaded shaft tensioning mechanism.

FIG. 27 is a section view showing the tissue repair system of FIG. 18with flared implant pusher.

FIG. 28 is a section view showing the tissue repair system of FIG. 27preloaded into the delivery system and place over a preformed hole inthe tissue.

FIG. 29 is a section view showing the soft anchoring implant of FIG. 28still housed within the inserter tube of the tissue repair deliverysystem after the inserter tube has been pushed to the bottom of thepreformed hole in the tissue.

FIG. 30 is a section view showing of the tissue repair delivery systemof FIG. 29 after the inserter tube has been retracted to expose the softanchoring implant.

FIG. 31 is a section view showing the tissue repair delivery system ofFIG. 30 after the soft anchoring implant has been deployed into itsanchoring state.

FIG. 32 is a section view of an embodiment of the tissue repair systemas used to repair a defect in soft tissue.

FIG. 33 is a section view of an embodiment of the tissue repair systemas used as a retention anchor on the outside surface of a bone.

FIG. 34 is a perspective view of an implant in accordance withembodiments.

FIG. 35 is a representation of installation of the implant of FIG. 34into a bicep in accordance with embodiments.

DETAILED DESCRIPTION

In the following description, various embodiments of the presentinvention will be described. For purposes of explanation, specificconfigurations and details are set forth in order to provide a thoroughunderstanding of the embodiments. However, it will also be apparent toone skilled in the art that the present invention may be practicedwithout the specific details. Furthermore, well-known features may beomitted or simplified in order not to obscure the embodiment beingdescribed.

The technology disclosed herein would have a broad application inorthopedic surgery for an animal, such as a human. This includes repairsof tendons to bone, bone to bone, tendons to tendons, and ligaments tobone, including ligament reconstruction. Some of these proceduresinclude, but are not limited to, labral repairs in the shoulder and hip,capsular plication, biceps tenodesis, anterior cruciate ligamentreconstructions, rotator cuff repairs, meniscal repair, triangularfibrocartilage (TFCC) repairs, and ankle stabilizations. There can alsobe an application for fracture repair, such as for repairing smallbutterfly fragments in long bone fractures.

Applications outside of orthopedic surgery include: cardiac surgery(where pledgets are used in the implantation of prosthetic heartvalves), general surgery (for hernia repair, nissen fundoplication, andparenchymal compression), plastic surgery (for tissue to tissue repair),Ob-Gyn (for cuff closure in laparoscopic hysterectomy and bladdersupport).

Referring now to the drawings, in which like reference numeralsrepresent like parts throughout the several views, FIG. 1 is aperspective view of a soft anchoring implant 100 with an associatedlength of suture 120 passed through it. When used as part of the tissuerepair system, the implant 100 is intended to anchor suture within boneor other hard tissue and allow for the further attachment of soft tissueas in an orthopedic repair. In embodiments, the soft anchoring implant100 may be loaded into a delivery system and deployed into hard tissuesuch as bone to facilitate a repair or deployed as a retaining anchorfor two pieces of soft tissue. In other embodiments, the tissue repairsystem may be utilized as described herein to facilitate the attachmentof synthetic tissue or materials to other structures within the body.

Generally described, the soft anchoring implant 100, isthree-dimensional, tubular shape with one open end 110 and one closedend 112 and defining a resident volume 200 (discussed in detail later).The implant would typically be sized in the range of 10 mm-30 mm inlength with a width or diameter of 2 mm-6 mm. A length of suture 120 ofthe type typically used in orthopedic repair procedures is shown passedoutside and around the proximal end of the soft anchoring implant 100 inFIG. 1 and subsequent figures. The suture 120 passes through the wall ofthe implant to the outside for a short distance before it passes back tothe inside of the implant, then out again and around the closed end ofthe implant before repeating the penetrations and exiting back outaround the open, proximal end of the implant 100. The suture length 120is not locked into place with respect to the soft anchoring implant 100,rather it remains slideable through or along the walls of the implant.This slideability aspect is important to the function of the implant asit relates to its ability to attach and repair tissues.

A second function of the suture length 120 is in the deployment aspectutilizing the tissue repair system. When the suture lengths aretensioned and some counter traction is applied at the end 110 of theanchoring implant 100, the anchoring implant shortens along its axis andin doing so expands radially. This radial expansion forces the anchoringimplant to assume a larger effective diameter than it had prior todeployment and larger than the hole into which it was inserted. Thus theanchoring aspect is achieved.

FIG. 2 shows an alternate embodiment of the soft anchoring implant withtwo suture lengths 120 passed through it in a side-by-side fashion.Alternatively, FIG. 3 shows the soft anchoring implant with two suturelengths 120 passed through it in a cross-over fashion. Having multiplesuture lengths may have the added benefit in the surgical procedure ofbeing able to anchor multiple pieces of tissue independently to the boneor other tissue where the soft anchoring implant resides. Multiplesutures also allows for the use of a greater variety of suturing andrepair techniques. Additionally, multiple suture strands may allow formore effective deployment of the soft anchoring implant into the bone orother hard tissue by virtue of the fact that they may inherently causemore wrinkling, folding, or puckering of the soft anchoring implant thusgiving it better retention properties.

In additional embodiments, the soft anchoring implant can include threeor more suture lengths associated with it. It is understood that thesesuture lengths may be configured in a sided-by-side fashion or in anyvariety of cross-over fashion. It is also understood that the suturelengths may initiate interface with the soft anchoring implant throughan inside of the lumen or from the outside the lumen and may enter andexit the walls of the soft anchoring implant once or multiple times.

FIG. 4 shows an embodiment of a soft anchoring implant 101 constructedfrom a flat section of braided material that has been rolled into a tubeor cone shape. The rolled structure 101 may be held together withadhesive or stitches and the free edge 104 of the braided material maybe bound further in similar methods. This rolling of the braidedmaterial may provide added thickness to the structure for the purposesof enhanced retention properties. Similar to other embodiments, thebraided material may be rolled upon itself in such a manner as topartially or completely close one end while leaving the opposite end 103substantially more open and creating a resident volume 200.Alternatively, it may be rolled into a straight tubular configurationwith both ends equally open or closed. As with other embodiments, alength of suture 120 may be stitched through the braided material tofacilitate the deployment of the soft anchoring implant.

FIG. 5 is another embodiment of a soft anchoring implant showing analternative layering construction. In this embodiment one braidedmaterial structure 106 is nested inside another braided materialstructure 107 to create a double-layered structure 108. Thisconstruction method may be multiplied as desired, to create triple-layerstructures and more. This layering configuration creates a structurewith thicker walls which may be advantageous for applications requiringhigher retention strength. This added thickness may also allow the useof a smaller gage suture strand(s) as the strand will be less likely todestructively pull through braided structure.

FIG. 6 shows yet another embodiment of the soft anchoring implant thatis formed from single or multiple continuous strands 114 of suture thatare coiled upon themselves to form a tubular construct that may containa resident volume 200. In this embodiment, the strand(s) 114 are coiledupon itself in a stacking fashion with the resulting geometry similar tothat of previous embodiments and defining a resident volume 200. Thelayers of coiled suture may be held together by a substrate such as anadhesive that allows it to remain soft and flexible. Alternatively thestacks may be bound together by tacking sutures. A suture length 120 maybe passed through braided material in a similar manner as priorembodiments. The coiled suture structure may be a straight tubularconfiguration with a consistent diameter or alternatively could beconical shaped, so as to have a very small diameter (even closed) on oneend with a much larger diameter on the other end.

FIG. 7 shows an alternate embodiment of the soft anchoring implant inwhich a distal end 128 is bound closed with stitching 129. Again, thesuture length 120 is passed through the soft anchoring implant,encompassing the closed end, with both free ends of suture 120 exitingthe implant outside and around the open end 130. It is understood thatthe bound end 128 may be closed by heat sealing or any other reasonablemethod of closing the end.

FIG. 8 shows an alternate embodiment of a soft anchoring implant inwhich one end 131 is bound closed by heat sealing. The suture length 120is passed through the soft anchoring implant, starting at the bound end,going down the side wall of the implant and encompassing the open end130, with both free ends of suture 120 exiting the implant at the boundend 131. It is understood that the bound end 131 may be closed bystitching or any other method of closing the end of the implant.

FIG. 9 shows an alternate embodiment of a soft anchoring implant inwhich both ends 133 are bound closed by heat sealing or stitching. Aswith other embodiments, the suture strand runs down one side of theimplant, around the opposite bound end and up the other side, with bothends of suture exiting the same end. As with other embodiments, thesuture may penetrate the walls of the implant one or more times. Thisembodiment may contain a resident volume that is completely enclosed.

FIGS. 10 through 13 are perspective views of alternate embodiments ofsoft anchoring implants with sutures. These figures represent variousmethods of constructing a three-dimensional tubular implant from a flatpiece of suture-based braided material. In FIG. 10, a flat rectangularlength of suture braided material has been folded in half such that thefolded portion 140 creates the closed end 146 of the soft anchoringimplant and the two free ends 142 are aligned to form the open end 148.The sides of the rectangular braided material where the edges 144 meetare bound closed with adhesive. It is important to note the two halvesof folded braided material are not bound all the way across, rather onlyat the edges so as to create an open space or resident volume 200 at thecenter of the three-dimensional soft anchoring implant. The residentvolume will be further discussed and defined later. As in previousembodiments, a suture length 120 may be threaded in-and-out of the softanchoring implant that encompasses the closed end 146, with both freesuture ends exiting around the open end 148.

FIG. 11 shows a soft anchoring implant similar that of FIG. 10 which hasbeen formed from a rectangular piece of suture-based braided materialthat has been folded in half upon itself. All aspects remain the sameexcept that in this embodiment, the two side edges of the braidedmaterial 144 have been bound closed by a running or interrupted stitch150 that runs the length of the implant. Again, only the edges are boundso as to create the resident volume.

FIG. 12 shows a soft anchoring implant similar that of FIGS. 10 and 11which has been formed from a rectangular piece of suture-based braidedmaterial or braided material that has been folded in half upon itself.All aspects remain the same except that in this embodiment, the two sideedges of the braided material have been heat-sealed closed as is acommon manufacturing technique with polymer-based braided materials andsuture. As before, the soft anchoring implant retains athree-dimensional configuration and may have a resident volume 200.

FIG. 13 shows a soft anchoring implant similar that of FIGS. 10-12 andwhich has been formed from a rectangular piece of suture-based braidedmaterial or braided material that has been folded in half upon itself.All aspects remain the same except that in this embodiment, the two sideedges of the braided material have been closed using a mattress-typestitch 154 that effectively binds the edges together without the stitchloop actually encompassing the open edges 144 themselves. As before, thesoft anchoring implant retains a three-dimensional configuration with aresident volume 200.

While it is stated that the soft anchoring implants shown in FIGS. 9through 13 may be constructed from a piece of rectangular-shaped braidedmaterial that is folded in half, it should be clear that the rectangularshaped braided material could be any elongated braided material shapeincluding two separated pieces of elongated braided material that areattached to one another to create a three-dimensional construct with aresident volume 200 as shown in the figures.

In the figures, the soft anchoring implant is in the form of a threedimensional structure like that of a sock or a closed end tube or afive-sided box. This three-dimensional structure preferably defines orincludes a predefined inner space or resident volume 200. The “residentvolume” is a volume that is intentionally formed by thethree-dimensional anchoring implant structure in its manufactured,predeployed or relaxed state. A resident volume as defined herein may beinherently thicker and/or wider than the thickness of the material fromwhich the structure is fabricated. For example, a flat piece of braidedmaterial with a hole in it may not define a resident volume (the hole),because the hole is only as deep as the thickness of the braidedmaterial. It is not necessarily a permanently open or enclosed volume.For example, as in the case of soft flexible braided materials, saidresident volume may exist upon manufacture and inherently in thestructure, but when the sides of the structure are compressed, theresident volume may become smaller or disappear altogether. The residentvolume may exist as manufactured in the structure of the anchoringimplant when the implant resides in an upright configuration but tend todisappear when the structure is on its side due to the forces of gravityon the soft, flexible braided material of the structure. However, theresident volume always exists within the structure when the structure isreturned to its original position and configuration. The term as it isused herein does not necessarily preclude the resident volume from beingfilled with some other substance at a given time nor does it precludethe structure folding or collapsing in on itself so as to temporarilyobscure the presence of the resident volume.

The soft anchoring implant as shown in FIGS. 1-13, is preferably a soft,flexible construct of braided yarns or fibers. It may be of benefit forthis construct to be constructed from known biocompatible materialscommonly used in orthopedic procedures such a suture. Typical materialsthat would be used to construct the implant may be but are notrestricted to Ultra high molecular weight polyethylene (UHMP),Polyester, Polyproylene, Silk or bioabsorbable materials typically usedfor suturing applications. The suture length 120 that is passed throughthe soft anchoring implant 100 is of a gage and material typically usedin orthopedic surgical procedures. For example, a #2 size suture lengthwould typically be used for the suture length 120 in a constructdesigned for rotator cuff repair or labrum repair in the shoulder. A #1suture can also be used with the smaller implants.

As mentioned earlier, the soft anchoring implant may be constructed of asoft, flexible construct of braided yarns or fibers. The orientation ofthe fibers within the construct as well as the actual fiber diameter andthe tick size of a braided material are of some importance in theexpansion of the soft anchoring implant during deployment. FIG. 14 showsan embodiment of the soft anchoring implant in the pre-deployed state160 in which the fibers are relaxed in an orientation neithersubstantially parallel with the axis 170 nor orthogonal to the axis 170of the construct. In this state the soft anchoring implant may assume awidth or diameter of “D” which is typically in the range of 0.1″ to0.25″ and a length of “L” which is typically in the range of 0.45″ to0.9″. The loose fiber or yarns at the open end may be bound to oneanother with heat sealing or other methods so as to prevent fraying.

The soft anchoring implant my then be placed into an en elongated andcompressed state as shown in FIG. 15. The fibers of the implant are morealigned in an orientation parallel to the axis 170 and are generallymore compacted. In this orientation, the soft anchoring implant isgenerally in a more elongated state and of a generally smaller diameterwith a typical width or diameter “D2” of 0.06″ to 0.150″ and length “L2”of 0.5″ to 1.0″. This implant may be pulled and manually manipulated toachieve this configuration or the use of specialized manufacturingfixtures may be employed, such as a funnel or a tube, which may compelthe implant to achieve this configuration to better fit within theinserter tube.

The embodiment shown in FIG. 15 is formed from a coarse braidedmaterial. More specifically, the structure utilized is a cylindrical,helically wound braid, such as the common biaxial braid. Pulling theentire braid along its length (i.e., putting the braid in tension)lengthens and narrows it. The length is gained by reducing the anglebetween the braided threads of the wound braid at the crossing points ofthe threads so that the braided threads align mostly parallel, whichalso reduces the radial distance between opposing sides and hence theoverall circumference. When counter traction occurs, the opposite actionoccurs, and the braid contracts axially and expands radially, in thiscase by increasing the angle between the braided threads. This helicallywound braid provides an advantage in that the structure can collapse andelongate naturally due to the alignment of the braids.

FIG. 16 shows the implant of FIG. 14 in its elongated, compressed stateand loaded into an inserter tube 310 in preparation for insertion intissue and eventual deployment. The easily collapsible structure of thehelically wound braid permits an installer to quickly and efficientlystretch the implant to the elongate position, and insert it into theinserter tube 310. Upon deployment of the soft anchoring implant bytensioning the sutures as described earlier, the fibers of the textileassume an orientation more orthogonally aligned 166 with respect to theaxis 170. FIG. 17 shows this postdeployed state 164, wherein the implantis generally shortened and of a larger diameter than in the pre-deployedstate 160. As described previously, the inherent fiber size in textileor braided material combined with the weave or opening or tick size mayimpact the ability of the implant to achieve varying degrees of thepredeployed and postdeployed states.

A fiber or yarn size of 200 to 1500 denier is generally appropriate witha braid of 7 to 25 pics per inch (PPI). Tightly braided constructs madeof small fibers, for example 100 denier at 50 PPI would not allow theorientation change of the fibers which facilitate the contraction andexpansion of the implant and thus inherently have lower retentionstrength. Woven constructs are similarly restricted in their expansioncapability due the orientation of the fiber weave.

The ratio of the implant length to diameter (or width) of the softanchoring implant may play some role in achieving better retentionproperties. For example, a longer implant of a given diameter may betteranchor itself in tissue by virtue of the fact that it would have moresurface area contact with the surrounding tissue or bone. Alternatively,there may be some benefit to a soft anchoring implant with a relativelylarge diameter (or width) in relation to the hole through which it ispushed. There are limitations to the diameter of the implant however, asimposed by the space within inserter tube used to deploy the implant.However, in embodiments, a soft anchoring implant may fit into aninserter tube or other delivery mechanism with a smaller diameter. Thisis possible because of the soft, flexible nature of the implant, withits combination of yarn size and pic count allowing it to elongate andcompress to a substantially smaller diameter to allow for placement intoan inserter tube without necessarily folding over on itself.

FIG. 18 is a section view of a deployment system 400 of the tissuerepair assembly. A hand piece 410 is shown with the inserter tube 310attached at the distal end. A slider 420 is operatively attached to animplant pusher 312 and moves it back and forth relative to the insertertube 310. The implant pusher 312 can be a rod or a tube, and if a tube,suture can be routed up the tube from the implant to a handle for thehand piece 410. The distal end 313 of the implant pusher 312 iscoaxially disposed within the inserter tube 310. In an alternateembodiment the implant pusher 312 may remain stationary with respect tothe handle 410, while the inserter tube 310 is moveable. The softanchoring implant 100 is shown disposed in the end of the inserter tube310 and resting just distal to the end of the implant pusher 312.

FIG. 19 is another embodiment of a delivery system. The hand piece 600is primarily comprised of a handle body 605 and a knob shell 606, with aslideable trigger 608 moveable within the handle body. Attached to thetrigger 608 is the inserter tube 602, such that retracting the trigger608 also retracts the inserter tube 602 relative to the implant pusher601 which is disposed coaxially within the inserter tube 602. Theimplant pusher 601 is immovably anchored to the handle body 604 via aset screw or other mechanical attachment or bonding means.

Disposed coaxially within and immovably attached to (via screws,adhesives or other mechanical fasteners) the knob shell 606 is a helixbushing 610 (FIG. 20) which has a helical groove cut through the wall. Ahelix pin 620 which protrudes from a post of the handle body 604 slideswithin the groove on the helix bushing 610. Thus by twisting the knobshell 606 with attached helix bushing 610, the helix pin 620 slides downthe groove in the helix pin 610 and moves the knob shell 606 with helixbushing distally by the length of the groove.

It is understood that this helix bushing with groove is a means oftranslating the twisting motion into a linear motion and this may beachieved using a thread-type mechanism as well.

At the proximal end of the knob shell 606 is the suture retention disc612 which has a hole through which the suture tails are threaded (notshown) and at least one suture post 613 onto which the suture tails areremovably attached when implant is loaded.

Turning back to the hand piece 600 in FIG. 19, a safety tab 614 sitsbehind the trigger 608 preventing it from being retracted. Once thesafety tab 614 is removed, the trigger 608 may be retracted and thusretracting the inserter tube 602 relative to the backstop and exposingthe implant (not shown).

FIG. 21A shows the delivery system of FIGS. 19-20 with an implant (notvisible) preloaded into the distal end of the inserter tube 602 andsuture tails 625 extending from the proximal end of the hand piece 600.The safety tab 614 is in place behind the trigger 608, indicating thatno deployment has taken place.

FIG. 21B shows the preloaded delivery system of FIG. 21A. In this viewthe safety tab 614 has been moved out of the way, and the trigger 608has been retracted, thus retracting the inserter tube 602 and exposingthe soft anchoring implant 627. At this stage, the soft anchoringimplant 627 is in its compressed, elongated state. In this state theimplant 627 is at a diameter roughly equivalent to the inner diameter ofthe insertion tube. There may be some inherent slight expansion indiameter of the implant as the inserter tube 602 is retracted fromaround it, thus allowing it to fill any empty space left by the insertertube.

FIG. 21C shows the delivery system of FIG. 21B with the knob shell 606shown in a retracted position. This was accomplished by twisting theknob shell 606 such that the helix (or screw thread) mechanism describedearlier effects a linear translation along the post 629 of the handlebody 604. By translating the knob shell 606 by the distance X, tensionis applied to the sutures 625 which are anchored to the suture retentiondisc 612 via the suture post 613. This tension applied to the suturescompresses the soft anchoring implant 627 and effects a change inorientation of the axially-aligned fibers or yarns to an orientationmore orthogonal to the axis, thus enlarging the effective diameter ofthe implant 627. The distance X is typically in the range of 0.75″ to 2″and inherently creates a tensile force Y on the sutures which in turncreates an equal compressive force on the implant. This tensile force Yis typically directly related to the travel distance X but alsodependent upon the resistance of the tissue, stiffness of the sutures,etc. This tensile force Y is ideally in the range of 50N to 200N forcein order to adequately tension the sutures to create good retention ofthe implant, particularly in bony tissue. An optimal configuration maytension the sutures a distance of approximately 1.6″, corresponding to atensile force in some tissue formations of about 140N. Alternatively, aninserter can be configured to apply a given force, regardless ofdistance travelled. For such embodiments, force could release due to afriction hold on the sutures, a breakaway tab, a measurement device, oranother structure or force measurement device.

It is important to note that the sutures may also be tensioned by handor with the use of some other tensioning mechanism. Tensioning suturesto a high force by hand can be difficult. As shown in FIG. 22, a simplepaddle 631 may be attached to the suture strands 625A. The trigger 608Aand the safety tab 614A are used as described above with FIG. 19. Thepaddle 631 in this embodiment may be attached to the side of the handlebody 604A when not in use. After pulling the trigger 608 to expose theimplant, the paddle 631 may be removed from the handle body and grippedto facilitate tensioning the sutures to adequately deploy the softanchoring implant in the bone. The paddle 631 may be any rigid orsemi-rigid material and may be of any shape that is readily grabbed byone's hand. In this embodiment, the suture strands 625A are passedthrough a hole in the center of the paddle 631 and wrapped multipletimes around the paddle. If a specific distance of pull is required,marks on the suture may be utilized. Alternately an in-line breakawaytab may be incorporated which would break when a threshold tensile forceis reached, thus assuring adequate tension on the suture. An example ofsuch a break-away tab may be a bar of plastic that is attached in-linewith the suture strand. Said bar may have a thinner and inherentlyweaker section within that is designed such that it will fracture orbreak when it reaches a give tensile load. A similar break-away tab maybe incorporated into the paddle and may be the point of attachment forthe suture strand.

FIG. 23 shows another embodiment of an inserter design with a suturetensioning mechanism. The trigger 608B and the safety tab 614B are usedas described above with FIG. 19. A lever-type mechanism is used here totension the sutures 625B. The lever 633 is mounted on a hinge 634 at theproximal end of the handle body 604B which allows the lever 633 to bepulled away from the handle body 604B by its distal end. The suturestrands 625B exit a hole 635 in the handle body 604B and pass through ahole in the lever 633 where they are wrapped around and tied, removingany slack. Following deployment of the implant by pulling the trigger608B, the lever 633 is pulled, which in turn tensions the suture 625B.This is a useful mechanism as the lever 633 provides a mechanicaladvantage which will allow tensioning of the suture 625B to a highforce. The rotation of the lever 633 can be limited a particular amountto provide the appropriate distance of pull on the implant, and/or aforce limiter could be provided on the lever.

FIG. 24 shows another suture tensioning mechanism. The trigger (notshown) and the safety tab (also not shown) are used as described abovewith FIG. 19. A rotatable knob is 637 is mounted on the distal end ofthe handle body 604C. The suture strand(s) 625C are fed up through thehandle body 604C, then through a slot in the outside of the rotatableknob 637 where it is knotted to prevent pull-through. Upon rotating theknob 637, the suture strand(s) is spooled around a groove in the outsideof the knob 637, thereby tensioning the suture.

FIG. 25 is an embodiment of a suture retention disc 612 with a suturepost 613. The suture strands 625 exit the handle body and pass through ahole 640 in the suture retention disc 612. The suture strands are thenwrapped around the post 613 one or more times before passing into a slot641 within the suture post 613. The slot is configured to a width suchthat the suture strands are wedged between the two inner faces of theslot. Upon exiting the slot, the suture strands may be wrappedadditional times around the post 613 and again through the slot 641. Bywrapping around the post 613 before passing through the slot 641, aself-tightening feature is created. When tension is applied to thesuture strands to expand the anchor, the portion of the strands that arewrapped around the post 613 apply a compressive force which effectivelynarrows the slot 641, creating a clamping force on the suture strandportion which runs through the slot, thus not allowing the suture toslip through the slot or around the post. This is important because itallows adequate tensioning of the sutures and thus adequate expansionand anchoring of the implant in the tissue.

In embodiments, the sharp corners 642, as opposed to a roundedconfiguration, may produce the effect of gripping the suture andpreventing slippage.

Other embodiments of the suture retention posts include, but are notlimited to, multiple posts on a single suture retention disc; multipleposts for attaching multiple sutures; posts directly attached to orintegral with the knob shell or helix bushing or threaded knob; postswith multiple slots in various configuration, such as crossing slots;posts of various shapes including round, square rectangular, triangular,domed etc.

FIG. 26 is a partial cutaway perspective view of a tissue repairdelivery system 700 with an internal threaded shaft tensioningmechanism. In this embodiment, a rotatable knob 702 is mounted on theback of the handle 701. A threaded piston 704 is mounted axially alongthe handle 701, and extends into the knob 702. The knob 702 includesinternal female threads for receiving the threaded piston 704, which canbe fixed so that it cannot rotate. The threaded piston may be fixed andprevented from rotation through the use of tabs 703 which extendorthogonal to the axis of the piston and slide within a slot defined onthe inside surface of the handle. The suture strands (not shown) areattached to the threaded piston 704.

When the knob 702 is rotated, the threaded piston 704 moves proximally,pulling the suture strands with it. This movement tensions the suturestrands. The amount of travel can be limited so as to provide theappropriate distance of pull and/or force on the suture strands.

Turning to FIG. 27, a section view is shown of the tissue repairassembly 300. The fibers or yarns soft anchoring implant 100 is shownloaded into the inserter tube 310. The inserter tube is preferably metaland its diameter is generally the same as the diameter of a hole 320that is drilled or otherwise formed in the cortical bone 322 andcancellous bone 324 into which the implant is to be inserted. A lengthof suture 120 is shown woven through the implant as described previouslywith the free ends of the suture exiting the open end of the softanchoring implant and subsequently exiting the inserter tube 310 and theimplant pusher 312. The implant pusher 312 is a preferably but notnecessarily metal tube with an outer diameter generally the same as (orslightly smaller than) the outer diameter of the soft anchoring implant100 and slightly smaller than the inner diameter of the inserter tube310.

A close but slideable fit between the outer diameter of the implantpusher 312 and the inner diameter of the inserter tube 310 aids inpreventing portions of the soft anchoring implant 100 from becomingwedged between the two tubes and provides generally better countertraction. In practice, however, a close fit between the outer diameterof the implant pusher 312 and the inner diameter of the inserter tube310 may be hard to achieve. In this case, as in FIG. 27, the end of theimplant pusher 312 may be configured to have a flare 313. Alternativelythe end may be configured in any other manner, such as a bead, roll oradditional component which will allow a closer fit to the inner diameterof the inserter tube or otherwise prevents pinching of the implant 100between the inserter tube 310 and the implant pusher 312. The lumen ofimplant pusher 312 is of sufficient diameter as to allow the freepassage of both ends of the suture 120. The inserter tube 310 withpreloaded soft anchoring implant 100 and implant pusher 312 are showninside the drill guide 314. The drill guide 314 is may be a metal tubewith an inner diameter just large enough to allow the free passage ofthe inserter tube 310. It serves the dual purpose of guiding the drillfor creating the hole in the bone as well as guiding the inserter tube310.

When the tissue repair system is used in a bone anchoring scenario suchas a rotator cuff repair or a labral repair, a hole 320 may be drilledinto the bone where the soft anchoring implant is to be placed. This maybe done using a standard orthopedic drill to a predetermined depth. Thedepth of the hole 320 is typically about the same as or slightly shorterthan the length of the implant. As mentioned previously, the hole isdrilled to a diameter roughly the same as the outer diameter of the softanchoring implant. When drilling the hole, the drill guide 314 may beused with the drill placed through it. Upon removing the drill from thedrill guide 314, the drill guide may be left in place and the insertertube 310 with the preloaded soft anchoring implant is positioned in thedrill guide as shown in FIG. 28.

As shown in FIG. 29, the inserter tube 310 with soft anchoring implanthoused inside may be pushed forward into the drilled hole 320. Theimplant pusher 312 also moves forward with the inserter tube 310 andremains close to or touching the proximal end of the implant.

Turning now to FIG. 30, another cross section view is provided showingthe subsequent step to FIG. 29 in the use of the tissue repair system.The implant 100 is shown placed into the hole 320 in a coaxialorientation. This is done by retracting the inserter tube 310 in anaxial direction while the implant pusher 312 remains in place. Theimplant pusher 312 is preferably connected on the proximal end to thehandle which is not moveable, while the inserter tube 310 is attached atits proximal end to an activation knob, slide, or trigger (e.g., thetrigger 608) housed within a handle which can be activated by the user.Once the inserter tube 310 has been retracted to the outermost level ofthe bone, the implant is left inside the preformed hole, exposed to thebone as shown in FIG. 30.

At this point, the sutures may be tensioned as shown in FIG. 31, withthe implant pusher 312 remaining stationary within the bone space. Theimplant pusher 312 ideally extends into the bone to the bottom of thecortical layer, typically 0.02″ to 0.05″ below the bone/tissue surface.As the sutures 120 are tensioned, the implant 100 retracts upon itselfwith the end of the implant pusher 312 providing counter traction andassumes a shorted, expanded state with an increased effective diameter.By “counter traction,” we mean a back stop is provided resistingmovement of the proximal end of the implant proximally, thus causing theimplant to bunch and expand.

Expansion is accomplished primarily by the orientation change of thefibers as discussed earlier. When the implant 100 increases in diameter,the soft anchoring implant becomes larger than the hole through which itwas inserted in the cortical bone 322, thus resisting pull out. The softanchoring implant 100 also embeds itself to some degree into thecancellous bone 324 that makes up the majority of the walls of the hole320. This is possible because in most cases, the cancellous bone 324 issignificantly softer than the associated cortical bone layer 322 aboveit. This “embedding” of the implant into the cancellous bone may alsocontribute to resistance of the implant to pull out. The soft anchoringimplant 100 is preferably placed into the bone in a lengthwise or axialorientation, such that one of the ends (the closed end or the open end)enters the bone first, with the opposite end entering last. In theembodiment of an implant with two closed ends, the end with the suturelength 120 encircling the distal end is preferably placed into the holefirst.

In an alternative embodiment, the hole 320 may be sized such that itwill not accept the inserter tube 310. In this embodiment, the insertertube 310 with the preloaded soft anchoring implant 100 is stopped at theentrance of the bone hole and a moveable implant pusher may be used topush the implant to the bottom of the hole 320. A stop mechanism mayalso be used here to prevent movement of the implant pusher 312 too farinto the hole 320.

Ina related embodiment of tissue repair system, a partial hole may bedrilled or punched. This hole may breach the cortical bone layer, yetnot penetrate the softer cancellous bone. The inserter tube may beconfigured with a temporarily closed end such that it may be forced bypushing or malleting so as to penetrate the cancellous bone and placethe implant at the desired depth. Alternatively, such a configuredtissue repair system may be used to penetrate the cortical bone as well.

Turning now to FIG. 32, a tissue repair system is shown which may beused to repair defects in soft tissue or attach two separate pieces ofsoft tissue. The soft anchoring implant may be substantially the same aspreviously disclosed herein. In the figure, a section of tissue 350 isshown with a tear or defect 352 that requires surgical repair and atissue repair assembly 500 which is configured with two soft anchoringimplants 100 and 102 (shown deployed). These implants may be of similarsize and configuration as previously disclosed herein. In the figure,the first soft anchoring implant 102 is shown already deployed against asection of tissue 354 distal to the tissue repair assembly 500. Thesharp edge 356 of the inserter tube 310 is used to penetrate the tissueand the defect, emerging on the distal side of the tissue 354. The softanchoring implant is pushed out of the inserter tube 310 by the implantpusher 312 and deployed by tensioning the suture 120. Tensioning thesuture pulls the implant against the tissue 354 which provides countertraction, thus allowing the implant to compress axially and expandradially as previously described.

A second soft anchoring implant 100 is shown still residing in theinserter tube 310 with the trailing suture 120 from the deployed implant102 passing through it. The suture 120 exits the open end of the implantas previously described. A sliding knot 358 is located within theinserter tube 310 behind the second implant 100. The implant pusher 312is used to push the sliding knot and the second implant 100 from theinserter tube 310. After tensioning the suture to deploy the secondimplant against a proximal portion of the tissue 355, the implant pusher312 is advanced to position the sliding knot against the deployedimplant. The suture 120 may then be trimmed to complete repair. A guidetube 315 may be used to position the inserter tube 310 against thetissue.

In an alternative embodiment, a jump stitch or mattress stitch may becreated by penetrating the tissue a second time at an adjacent location360 and deploying the second implant 100 at a second distal tissuelocation 362. The inserter tube may be configured with a slot at thedistal end to facilitate this technique by allowing the suture strand toremain on the proximal side of the tissue during the second penetration.

FIG. 33 shows a tissue repair system used as a retention anchor on theoutside of a bone as might be done in attaching a graft ligament in anACL repair. In this embodiment, a soft anchoring member 102 is shown ina deployed state outside the distal end 370 of channel 371 bored throughthe bone 372. A similar tissue repair system configuration may be usedto deploy the soft anchoring implant 102 as has been disclosed inprevious embodiments. In this embodiment a tissue graft 373 may bepre-attached to the suture 120 associated with the soft anchoringimplant 102. In this embodiment, the soft anchoring implant 102 maypreferably be sized such that its diameter is inherently larger than thehole through which it is placed, thus providing better retentionproperties. Because of the flexible nature of the implant 102, it may befolded or compressed to fit into the inserter tube that is smaller thanits inherent diameter as in all other embodiments disclosed herein.

FIG. 34 shows another embodiment of a soft anchoring implant 800 whichmay be used for attaching a tendon to a bone. In this embodiment twosuture strands are communicated with the implant. The ends (1 b and 2 b)of the suture strands are configured with needles.

FIG. 35 shows the biceps muscle and associated biceps tendon. Theneedles (1b and 2 b) are passes through the biceps tendon in a crossingor whipstitch fashion to permanently connect the suture to the tendon. Ahole is drilled through the radial bone and the soft anchoring implant800 is passed all the way through the bone and deployed on the oppositeside of the bone. The suture strands (1 a and 2 a) are then thentensioned to approximate the biceps tendon to the bone and into thedrilled hole. Tensioning the sutures (1 a and 2 a) also produces theeffect of further expanding the soft anchoring implant 800 on theopposite side of the bone to provide better retention. The suture endsare then trimmed and tied off.

In another embodiment, a tunnel may be created through adjacent bones,with the inserter being passed through both bones in a similar fashionto FIG. 35

Other variations are within the spirit of the present invention. Thus,while the invention is susceptible to various modifications andalternative constructions, certain illustrated embodiments thereof areshown in the drawings and have been described above in detail. It shouldbe understood, however, that there is no intention to limit theinvention to the specific form or forms disclosed, but on the contrary,the intention is to cover all modifications, alternative constructions,and equivalents falling within the spirit and scope of the invention, asdefined in the appended claims.

The use of the terms “a” and “an” and “the” and similar referents in thecontext of describing the invention (especially in the context of thefollowing claims) are to be construed to cover both the singular and theplural, unless otherwise indicated herein or clearly contradicted bycontext. The terms “comprising,” “having,” “including,” and “containing”are to be construed as open-ended terms (i.e., meaning “including, butnot limited to,”) unless otherwise noted. The term “connected” is to beconstrued as partly or wholly contained within, attached to, or joinedtogether, even if there is something intervening. Recitation of rangesof values herein are merely intended to serve as a shorthand method ofreferring individually to each separate value falling within the range,unless otherwise indicated herein, and each separate value isincorporated into the specification as if it were individually recitedherein. All methods described herein can be performed in any suitableorder unless otherwise indicated herein or otherwise clearlycontradicted by context. The use of any and all examples, or exemplarylanguage (e.g., “such as”) provided herein, is intended merely to betterilluminate embodiments of the invention and does not pose a limitationon the scope of the invention unless otherwise claimed. No language inthe specification should be construed as indicating any non-claimedelement as essential to the practice of the invention.

Preferred embodiments of this invention are described herein, includingthe best mode known to the inventors for carrying out the invention.Variations of those preferred embodiments may become apparent to thoseof ordinary skill in the art upon reading the foregoing description. Theinventors expect skilled artisans to employ such variations asappropriate, and the inventors intend for the invention to be practicedotherwise than as specifically described herein. Accordingly, thisinvention includes all modifications and equivalents of the subjectmatter recited in the claims appended hereto as permitted by applicablelaw. Moreover, any combination of the above-described elements in allpossible variations thereof is encompassed by the invention unlessotherwise indicated herein or otherwise clearly contradicted by context.

All references, including publications, patent applications, andpatents, cited herein are hereby incorporated by reference to the sameextent as if each reference were individually and specifically indicatedto be incorporated by reference and were set forth in its entiretyherein.

1-19. (canceled)
 20. A soft anchor system for tissue repair comprising:an insertion instrument; a soft anchor disposed at the insertioninstrument distal end, the soft anchor including distal and proximalends, and a resident inner space extending therebetween, the residentinner space defined by braided walls of the soft anchor; a sutureoperatively coupled to the soft anchor such that tension on the sutureis configured to deploy the soft anchor, laterally expanding the softanchor and longitudinally reducing the soft anchor and alsosubstantially eliminate the resident inner space.
 21. The soft anchorsystem of claim 1 wherein the insertion instrument comprises atensioning actuator operatively coupled to the suture, the tensioningactuator configured to tension the suture to a predetermined distance orpredetermined force.
 22. The soft anchor system of claim 2 wherein theinsertion instrument includes a back stop member engaged with the softanchor, configured to provide counter traction while actuating thetensioning actuator.
 23. The soft anchor system of claim 1 wherein theinsertion instrument includes an outer tube and an inner body disposedwithin the outer tube, the outer tube and inner body axially slideablerelative to each other, the outer tube having a distal open endconfigured to house the soft anchor therein.
 24. The soft anchor systemof claim 4 wherein the suture extends from the soft anchor and throughthe insertion instrument and couples to a tensioning actuator of theinsertion instrument, the tensioning actuator configured to tension thesuture to a predetermined distance or predetermined force.
 25. The softanchor system of claim 5 wherein the inner body is configured to engagea proximal end of the soft anchor and limit proximal movement of thesoft anchor during deployment.
 26. The soft anchor system of claim 1wherein the suture is woven through the soft anchor and around theresident inner space.
 27. The soft anchor system of claim 4 wherein theouter tube includes a sharp distal edge configured to penetrate tissue.28. The soft anchor system of claim 1 wherein the soft anchor forms anoval shaped bundle upon deployment.
 29. The soft anchor system of claim9 wherein the oval shaped bundle bunches up against an instrument bodydistal end during deployment.
 30. A soft anchor system for installingwithin a tissue: an insertion instrument including a tensioning actuatorat a proximal end of the insertion instrument, and an outer tube and astationary inner body extending distally therefrom, the stationary innerbody coaxially disposed within the outer tube, the outer tube configuredto axially slide relative to the inner body; a soft anchor includingopposite distal and proximal ends housed within a distal end of theouter tube and distal to the inner body; a suture operatively coupled tothe soft anchor and also operatively coupled to the tensioning actuator;wherein tension on the suture bunches the soft anchor up against theinner body and radially expands the soft anchor, and wherein thetensioning actuator is configured to apply and limit the tension. 31.The soft anchor system of claim 11 wherein the soft anchor includesbraided walls that define a resident inner space and wherein tension onthe suture eliminates the resident inner space.
 32. The soft anchorsystem of claim 11 wherein the inner body is a tube.
 33. The soft anchorsystem of claim 11 wherein the suture is woven through the soft anchorand around a distal end of the soft anchor.
 34. The soft anchor systemof claim 11 wherein the outer tube includes a sharp distal edgeconfigured to penetrate tissue.
 35. The soft anchor system of claim 11wherein the soft anchor forms an oval shaped bundle when installedwithin the tissue.
 36. A method of deploying a soft anchor into atissue; positioning a distal end of an outer tube of a soft anchorinsertion instrument within the tissue, the outer tube housing a softanchor therein; axially retracting the outer tube to expose the softanchor to the tissue, the anchor insertion instrument having astationary backstop configured to maintain the soft anchor within thetissue while axially retracting; tensioning a suture that is coupled tothe soft anchor while the backstop engages the soft anchor, anddeploying the soft anchor into a laterally expanded configuration withinthe tissue, the tensioning to a predetermined distance or force.
 37. Themethod of claim 17 wherein positioning a distal end of the outer tubecomprises positioning a distal edge surface of the outer tube adjacent abottom of a preformed cavity within the tissue.
 38. The method of claim17 wherein positioning a distal end of the outer tube comprises piercingthe tissue with a distal edge surface of the outer tube to form a cavityto receive the soft anchor therein.
 39. The method of claim 17 furthercomprising operatively coupling a repair tissue to the soft anchor. 40.The method of claim 17 wherein tensioning the suture gathers the softanchor, longitudinally shortening and radially expanding the soft anchorto form an ovoid shaped bundle.
 41. The method of claim 17 whereintensioning comprises actuating a tensioning actuator of the insertioninstrument, the actuator comprising tension limiting means.